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Background: Novel approaches that allow early diagnosis and treatment monitoring of both human immunodeficiency virus-1 (HIV-1) and tuberculosis disease (TB) are essential to improve patient outcomes.

Methods: We developed and validated an immuno-affinity liquid chromatography-tandem mass spectrometry (ILM) assay that simultaneously quantifies single peptides derived from HIV-1 p24 and Mycobacterium tuberculosis (Mtb) 10-kDa culture filtrate protein (CFP10) in trypsin-digested serum derived from cryopreserved serum archives of cohorts of adults and children with/without HIV and TB.

Results: ILM p24 and CFP10 results demonstrated good intra-laboratory precision and accuracy, with recovery values of 96.7% to 104.6% and 88.2% to 111.0%, total within-laboratory precision (CV) values of 5.68% to 13.25% and 10.36% to 14.92%, and good linearity (r2 > 0.99) from 1.0 to 256.0 pmol/L and 0.016 to 16.000 pmol/L, respectively. In cohorts of adults (n = 34) and children (n = 17) with HIV and/or TB, ILM detected p24 and CFP10 demonstrated 85.7% to 88.9% and 88.9% to 100.0% diagnostic sensitivity for HIV-1 and TB, with 100% specificity for both, and detected HIV-1 infection earlier than 3 commercial p24 antigen/antibody immunoassays. Finally, p24 and CFP10 values measured in longitudinal serum samples from children with HIV-1 and TB distinguished individuals who responded to TB treatment from those who failed to respond or were untreated, and who developed TB immune reconstitution inflammatory syndrome.

Conclusions: Simultaneous ILM evaluation of p24 and CFP10 results may allow for early TB and HIV detection and provide valuable information on treatment response to facilitate integration of TB and HIV diagnosis and management.

Titel:	Sensitive Blood-Based Detection of HIV-1 and Mycobacterium tuberculosis Peptides for Disease Diagnosis by Immuno-Affinity Liquid Chromatography-Tandem Mass Spectrometry: A Method Development and Proof-of-Concept Study.
Autor/in / Beteiligte Person:	Li, L ; Lyon, CJ ; LaCourse, SM ; Zheng, W ; Stern, J ; Escudero, JN ; Murithi, WB ; Njagi, L ; John-Stewart, G ; Hawn, TR ; Nduba, V ; Abdelgaliel, W ; Tombler, T ; Horne, D ; Jiang, L ; Hu, TY
Zeitschrift:	Clinical chemistry, Jg. 69 (2023-12-01), Heft 12, S. 1409
Veröffentlichung:	2020- : Oxford : Oxford University Press ; <i>Original Publication</i>: Baltimore, Md. : P.B. Hoeber, [c1955-, 2023
Medientyp:	academicJournal
ISSN:	1530-8561 (electronic)
DOI:	10.1093/clinchem/hvad173
Schlagwort:	Adult Child Humans Tandem Mass Spectrometry Peptides Chromatography, Liquid Sensitivity and Specificity Mycobacterium tuberculosis HIV-1 HIV Infections diagnosis
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Research Support, N.I.H., Extramural Language: English [Clin Chem] 2023 Dec 01; Vol. 69 (12), pp. 1409-1419. MeSH Terms: Mycobacterium tuberculosis* ; HIV-1* ; HIV Infections* / diagnosis ; Adult ; Child ; Humans ; Tandem Mass Spectrometry ; Peptides ; Chromatography, Liquid ; Sensitivity and Specificity References: PLoS Med. 2011 Jul;8(7):e1001064. (PMID: 21814497) ; BMC Med. 2017 Nov 1;15(1):188. (PMID: 29089034) ; Lancet Infect Dis. 2017 Apr;17(4):441-450. (PMID: 28063795) ; J Microbiol Immunol Infect. 2017 Aug;50(4):440-447. (PMID: 26433754) ; Tuberculosis (Edinb). 2008 Nov;88(6):510-7. (PMID: 18640874) ; N Engl J Med. 2011 Jul 7;365(1):21-31. (PMID: 21732834) ; Theranostics. 2022 Mar 21;12(6):2948-2962. (PMID: 35401822) ; Sex Transm Dis. 2017 Dec;44(12):739-746. (PMID: 29140890) ; Clin Chem. 2018 May;64(5):791-800. (PMID: 29348166) ; Clin Chem. 2018 May;64(5):763-765. (PMID: 29483104) ; Tuberculosis (Edinb). 2019 Sep;118:101863. (PMID: 31561185) ; J Infect Dis. 2015 Apr 1;211 Suppl 2:S21-8. (PMID: 25765103) ; Clin Infect Dis. 2015 Oct 15;61Suppl 3:S179-87. (PMID: 26409281) ; Am J Obstet Gynecol. 2018 Oct;219(4):408.e1-408.e9. (PMID: 29913173) ; Life (Basel). 2020 Oct 29;10(11):. (PMID: 33138069) ; Lancet Respir Med. 2015 Jun;3(6):451-61. (PMID: 25812968) ; Proc Natl Acad Sci U S A. 2017 Apr 11;114(15):3969-3974. (PMID: 28348223) ; Mol Microbiol. 2004 Jan;51(2):359-70. (PMID: 14756778) ; Nat Biomed Eng. 2022 Aug;6(8):979-991. (PMID: 35986185) Grant Information: R01 AI162152 United States AI NIAID NIH HHS; U01 CA252965 United States CA NCI NIH HHS; D43 TW011817 United States TW FIC NIH HHS; R01 AI175618 United States AI NIAID NIH HHS; UH2 AI152621 United States AI NIAID NIH HHS; R21 AI143341 United States AI NIAID NIH HHS; R01 HD090927 United States HD NICHD NIH HHS; P30 AI027757 United States AI NIAID NIH HHS; R01 AI150815 United States AI NIAID NIH HHS; R01 HD103511 United States HD NICHD NIH HHS; R21 NS130542 United States NS NINDS NIH HHS; R01 AI144168 United States AI NIAID NIH HHS Substance Nomenclature: 0 (Peptides) Entry Date(s): Date Created: 20231113 Date Completed: 20231204 Latest Revision: 20240404 Update Code: 20240405 PubMed Central ID: PMC10965313

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Sensitive Blood-Based Detection of HIV-1 and Mycobacterium tuberculosis Peptides for Disease Diagnosis by Immuno-Affinity Liquid Chromatography-Tandem Mass Spectrometry: A Method Development and Proof-of-Concept Study.